Status:
COMPLETED
Randomized Trial Sorafenib-Pravastatin Versus Sorafenib Alone for the Palliative Treatment of Child-Pugh A Hepatocellular Carcinoma
Lead Sponsor:
Centre Hospitalier Universitaire Dijon
Conditions:
Child-Pugh A Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Principal objective: to evaluate the effect of the combination pravastatin - sorafenib versus sorafenib alone on overall survival in patients with hepatocellular carcinoma developing on Child-Pugh A c...
Eligibility Criteria
Inclusion
- Hepatocellular carcinoma diagnosed by:
- either a histological examination
- or if histological evidence cannot be obtained (ascites, coagulation disorders) the diagnosis can be made in cases of cirrhosis according to EASL/AASLD 2005 criteria, by revealing a hepatic focal lesion of more than 10 mm
- on two dynamic imaging techniques (helical CT-scan, MRI, contrast-enhanced ultrasound) for tumours measuring less than 2 cm. The lesion must be characterised by hyperdensity during the arterial phase and wash-out during the delayed portal phase Patients who are not suitable for treatment with a curative intent (transplantation, resection, percutaneous destruction) or by chemo-embolisation or with progressive hepatocellular carcinoma after the failure of specific treatment Prognostic CLIP score 0 to 4 Child-Pugh Class A Transaminases ≤ 5 N and Creatininemia ≤ 1.5 N WHO: 0, 1 or 2 Age more than 18 years Foreseeable survival \> 12 weeks Possibility of regular follow-up Written informed consent
Exclusion
- Extra-hepatic disease that could be life-threatening in the short or medium term Another progressive cancer with the exception of in situ cervical cancer, a superficial bladder tumour and treated basocellular carcinoma.
- Any other cancer treated with a curative intent in the previous 3 years can be included in the study Heart failure (≥New York Heart Association class 2), uncontrolled AHT or arrhythmia, myocardial infarction in the previous 6 months Digestive haemorrhage in the previous month Patients who are receiving or have already received treatment with statins or sorafenib Pregnancy and breast-feeding. Women of child-bearing age must use an effective method of contraception throughout the trial and for 3 months after the end of the treatment.
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
474 Patients enrolled
Trial Details
Trial ID
NCT01903694
Start Date
March 1 2010
Last Update
May 13 2014
Active Locations (1)
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1
CHU de Dijon
Dijon, France, 21079